MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 0.9% SODIUM CHLORIDE IRRIGATION, USP, 3000 ML UROMATIC PLASTIC CONTAINER; SYSTEM, IRRIGATION, UROLOGICAL

Model Number 2B7127

Device Problems Defective Device (2588); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2020

Event Type  malfunction  

Event Description

During a ureteroscopy with laser lithotripsy, there were a total of 3 defective large pressure bags to pressurize 3l ns until finally the 4th pressure bag appeared to be working this led to the surgeon becoming very upset, but the amount of squeezing on these bags was a struggle.

• Brand Name: 0.9% SODIUM CHLORIDE IRRIGATION, USP, 3000 ML UROMATIC PLASTIC CONTAINER
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 10605420
• MDR Text Key: 209139329
• Report Number: 10605420
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2B7127
• Device Catalogue Number: 2B7127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Date Report to Manufacturer: 09/30/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA